- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02162901
The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs (DiaBEAT-it)
2021년 4월 1일 업데이트: Virginia Polytechnic Institute and State University
The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e.
impaired fasting glucose or impaired glucose tolerance) within a health care setting.
The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications.
While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge.
The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs.
Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group.
Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1.
A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up.
Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC).
SC includes the referral to a currently offered pre-diabetes class.
Primary outcome measures include weight loss, cost, and reach of each program.
Secondary outcome measures include physical activity behavior; eating behavior; and process evaluation.
It is hypothesized that both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than SC but will not differ from one another.
The investigators also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
597
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Virginia
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Roanoke, Virginia, 미국, 24016
- Virginia Tech Translational Obesity Research Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- age = or > 18 years
- BMI = or > 25
Exclusion Criteria:
- Patient's medical record contains ICD-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease
- Pregnant or becomes pregnant during trial
- Contraindication to physical activity or weight loss
- No access to phone
- Does not speak or read English
- Patient has indicated "Do Not Contact" in Carilion patient record
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Choice-Class with IVR Calls
Participants enrolled in this arm of the study will have chosen to attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months.
|
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions.
After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone call over a period of 12 months.
|
|
실험적: Choice-DVD with IVR calls
Participants enrolled in this arm of the study will have chosen to watch a DVD at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months
|
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions.
After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
|
|
실험적: Random-Class with IVR calls
Participants randomized to this arm of the study will be randomized a second time into one of three groups.
Participants in this group will attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months
|
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions.
After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
|
|
실험적: Random-DVD with IVR calls
Participants randomized to this arm of the study will be randomized a second time into one of three groups.
Participants in this group will be given a DVD to watch at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months
|
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions.
After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
|
|
활성 비교기: Random-Class only
Participants randomized to this arm of the study will be randomized a second time into one of three groups.
Participants in this group will attend one 2-hour class to be introduced to the intervention and will receive a workbook to use at home.
|
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions.
After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through a printed workbook.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body weight
기간: 12 months
|
Weight as measured by clinical scale at baseline, and 12 months.
|
12 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Fabio A Almeida, PhD, MSW, Virginia Polytechnic Institute and State University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 3월 13일
기본 완료 (실제)
2017년 1월 5일
연구 완료 (실제)
2017년 4월 28일
연구 등록 날짜
최초 제출
2014년 6월 11일
QC 기준을 충족하는 최초 제출
2014년 6월 12일
처음 게시됨 (추정)
2014년 6월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 1일
마지막으로 확인됨
2021년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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